Azo Gesic

Name: Azo Gesic

Directions

Directions

  • Adults: Take 2 tablets 3 times daily with or after meals as needed for up to two days.  Take with a full glass of water.  Do not use for more than 2 days (12 tablets) without consulting a doctor.
  • Children under 12: Do not use without consulting a doctor.
  • See enclosed insert for more information

Other Information

Other Information

  • This product can interfere with laboratory tests including urine, glucose (sugar), and ketones tests
  • This product may stain soft contact lenses and other items if handled after touching tablets
  • Long-term administration of phenazopyridine hydrochloride has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine hydrochloride and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
  • Store at room temperature 15º - 30ºC (59º-86º F) in a dry place and protect from light.

Tamper evident: Product is dealed in cellophane.  Do not use if cellophane is open or damaged.

Questions?

  • To report adverse drug event call: (800) 616-2471

Inactive Ingredients

Inactive ingredients  Lactose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze and sodium starch glycolate.

Principal Display Panel

AZO-GESIC

Urinary Pain Relief   

  • For Prompt, Temporary Relief of Minor Pain, Burning and Discomfort of Urination

30 Tablets

95 mg Phenazopyridine Hydrochloride

Azo Gesic 
phenazopyridine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0904-5025
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENAZOPYRIDINE HYDROCHLORIDE (PHENAZOPYRIDINE) PHENAZOPYRIDINE HYDROCHLORIDE 95 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SHELLAC  
SODIUM STARCH GLYCOLATE TYPE A CORN  
Product Characteristics
Color BROWN (Maroon) Score no score
Shape ROUND (Tablet) Size 7mm
Flavor Imprint Code CPC64
Contains     
Packaging
# Item Code Package Description
1 NDC:0904-5025-46 15 BLISTER PACK in 1 BOX
1 2 TABLET in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/25/2011
Labeler - Major Pharmaceuticals (191427277)
Revised: 10/2014   Major Pharmaceuticals

What is Azo-Gesic (phenazopyridine)?

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat urinary symptoms such as pain or burning, increased urination, and increased urge to urinate. These symptoms can be caused by infection, injury, surgery, catheter, or other conditions that irritate the bladder.

Phenazopyridine will treat urinary symptoms, but this medication will not treat a urinary tract infection.. Take any antibiotic that your doctor prescribes to treat an infection.

Phenazopyridine may also be used for purposes not listed in this medication guide.

What other drugs will affect Azo-Gesic (phenazopyridine)?

Other drugs may interact with phenazopyridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Commonly used brand name(s)

In the U.S.

  • Azo-Gesic
  • Azo-Septic
  • Azo-Standard
  • Baridium
  • Phenazo 95
  • Prodium
  • Pyridiate
  • Pyridium
  • RE-Azo
  • Urinary Pain Relief
  • Uristat
  • UTI Relief

Available Dosage Forms:

  • Tablet
  • Kit

Therapeutic Class: Analgesic

Before Using Azo-Gesic

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of phenazopyridine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
  • Hepatitis or
  • Kidney disease—The chance of side effects may be increased.

Precautions While Using Azo-Gesic

Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .

Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.

For patients who wear soft contact lenses:

  • It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.

For diabetic patients:

  • This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Phenazopyridine Identification

Substance Name

Phenazopyridine

CAS Registry Number

94-78-0

Drug Class

Anesthetics, Urinary

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